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510(k) K252355

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing by Sb-Kawasumi Laboratories, Inc. — Product Code PTI

K252355 is an FDA 510(k) premarket notification submitted by Sb-Kawasumi Laboratories, Inc. for the device "K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing". The FDA issued a decision of Substantially Equivalent on November 26, 2025. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. Sb-Kawasumi Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2025
Date Received
July 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Coring (Huber) Needle
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Other clearances by Sb-Kawasumi Laboratories, Inc.

  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
  • K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (June 1, 2023)
  • K223810 — Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (February 24, 2023)
  • K220799 — K-SHIELD Zen (August 29, 2022)

Other clearances for product code PTI

  • K251138 — Promisemed Safety Huber Needles (May 13, 2025)
  • K243332 — Promisemed Safety Huber Needles (March 14, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K230715 — Promisemed Safety Huber Needle (June 8, 2023)
  • K213823 — Intera Refill Kit (March 16, 2022)
  • K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolu (October 14, 2021)
  • K200463 — Huber Needle Infusion Set, Safety Huber Needle Infusion Set (April 7, 2021)
  • K170881 — ISP Safety Huber Needle Infusion Set (December 14, 2017)
  • K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle wit (November 3, 2017)
  • K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (August 8, 2017)

FDA data resources